Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

Not Applicable

Completed

• Conditions: Psychological Stress; Depression; Anxiety
• Interventions: Behavioral: mindfulness intervention; Behavioral: Conventional parent Support Group

• Registration Number: NCT01110343
• Lead Sponsor: Vanderbilt University

Brief Summary

This application compares the effectiveness of a conventional Parent Group intervention to Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum disorders (ASD) and other disabilities. Parent groups are widely-used to provide information, emotional support, education and advocacy. MBSR is efficacious for people with medical, psychiatric or other concerns, and teaches stress reduction through mindfulness training and practice. In contrast to conventional parent groups, the investigators' studies suggest that mindfulness-based interventions may be particularly effective in reducing stress and improving the health and mental health of parents of children with disabilities. The investigators will assess parent factors that may correlate with intervention efficacy in the 2 treatment arms.

Detailed Description

Specific Aim 1. To compare the effectiveness of Parent Groups versus MBSR interventions in parents of children with ASD or other developmental disabilities.

Hypothesis 1: Mothers and fathers in both treatment groups will show reduced stress, depression, and anxiety, and increased life satisfaction, health, and well-being. Treatment effects will be more pronounced in MBSR, including more normalized diurnal cortisol patterns.

Hypothesis 2: Improved parental outcomes will persist after treatment, and relate to booster session attendance, and/or the frequency that parents practice techniques learned in each treatment. Improvements will be sustained longer in the MBSR treatment. Parental benefits will impact families, and may be associated with improved child behaviors or less family conflict.

Hypothesis 3. The composition of intervention groups in Year 2 will be adjusted based on Year 1 data, and may reflect continued separation or integration of ASD vs other disability groups, or new combinations of participants.

Specific Aim 2: To identify aspects of maternal, family or child functioning that help explain variability in responses to Parent Group or MBSR interventions.

Hypothesis 4: Mothers or fathers with relatively more stress, health or mental health problems, will show more robust treatment responses. Variability in treatment responses may be associated with child age, maternal age, family ethnicity, and child behavior problems.

Hypothesis 5. Outcomes may relate to factors in the interventionists, greater treatment responses will be found when parents are matched with peer-mentors of the same gender, ethnicity, and child diagnosis.

Study Timeline

• Study Start: 2010-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-26
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• parent of a child with a known developmental disorder
• parent of a child with a chronic medical condition with known lifelong physical and mental effects, e.g., childhood cancer, cystic fibrosis, and muscular dystrophy

Exclusion Criteria

• those who are not parent of a child with a known developmental disorder or medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mindfulness intervention group	mindfulness intervention	Mindfulness intervention is a formatted curriculum based on Mindfulness based stress reduction techniques which have proven effective in reducing stress related to pain, everyday living and medical and psychiatric disorders.
conventional parent support group	Conventional parent Support Group	a 6 week behavioral program, with weekly 1.5 hour sessions with a trained parent mentor, 3 monthly booster sessions and follow-up.

Primary Outcome Measures

Name	Time	Method
Parenting Stress Index Scores	day 1 of week 6, active intervention phase	Parenting Stress Index standard scores will show treatment effects of intervention by day one of week six of active intervention phase.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory, Parenting Stress Index, Epworth Sleep Scale, Positive Affect Index, Life Satisfaction Scale, Mindfulness Questionnaire, Ryff's Well being Scale, Health Questionnaire, Achenbach Child Behavior Checklist	at day 1 of week six -active intervention phase	This standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.
Beck Anxiety Inventory	at day one of week 6, active intervention phase	This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.
Salivary Cortisol measures	at day 1 of week 6, active intervention phase	Diurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.
Ryff's scale of Well-being	on day 1 of week 6, active intervention phase	This self report measure of well-being will show treatment effects of interventions on week 6.

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States